MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-07-31 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[81474940]
The subject product was returned for evaluation and visually inspected. The outer carton has an indent/creasing as found during review. Received inside of the outer carton was an unopened product applicator kit blister tray and the chemistry kit blister tray. No damage was found to the chemistry kit inner blister tray. The chemistry kit was received with the tyvek lid peeled open. The albumin glass cartridge inside was broken and the peg glass cartridge remained intact. The product outer carton was damaged but when this damage occurred cannot be determined. At this time, we are unable to reach a definitive conclusion as to how and when the vial became damaged. A review of the manufacturing records was performed and found that the lot was manufactured to specification. The ifu for the progel product prescribes the proper instructions and precautions for this device to inspect for damage to the product and to prevent damage to the product during use. This file represents the third progel device used. Two additional mdr's are being submitted to represent the additional progel devices used. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[81474941]
As reported by the user facility: it was reported that in preparation for a case, three progel cartons were opened for use and all three albumin glass cartridges were found broken in the chemistry kits. A fourth unit was used in the case with no issues reported. It was reported that there was no damage noted to the outer cartons. The progel kits had been placed in the refrigerator for storage and at that time there was no damage identified. The refrigerator is well above freezing and the product was not frozen while in inventory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00478 |
| MDR Report Key | 6755280 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-07-31 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-05 |
| Device Manufacturer Date | 2017-06-12 |
| Date Added to Maude | 2017-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA SMITH |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258449 |
| Manufacturer G1 | NEOMEND INC -2953195 |
| Manufacturer Street | 60 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGEL PLUERAL AIR LEAK SEALANT |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2017-07-31 |
| Returned To Mfg | 2017-07-11 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 170607-001 |
| Device Expiration Date | 2018-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-31 |